A Clinical Study of the Paradise™ Renal Denervation System in Patients With Hypertension (RADIANCE-HTN DUO)

Hypertension Clinical Trial

Official title:

A Clinical Study of the Ultrasound Renal Denervation System (PRDS-001) in Patients With Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05326230
• Other study ID #: RDN-21-002
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 2029

Study information

• Verified date: March 2024
• Source: Otsuka Medical Devices Co., Ltd. Japan
• Contact: Mikiko Haraguchi
• Phone: +81 3 6361 7459
• Email: OtsukaRegistry-CT[@]otsuka.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the antihypertensive effect of renal denervation with the Paradise™ system with that of a sham procedure in hypertensive patients receiving two antihypertensive drugs at the time of consent, and treated with a duo combination antihypertensive pill.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: December 2029
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria :

• Patients who have received antihypertensive treatment with two antihypertensive drugs (ARB/ACE inhibitor and Ca channel antagonist, either as a single agent or as a combination) for at least 4 weeks prior to obtaining consent, with no change in the type or dosage.
• Patients with a mean seated office blood pressure of between 140 mmHg and 180 mmHg systolic and between 90 mmHg and 110 mmHg diastolic at screening visit.
• Patients with a mean 24-hour ABPM (ambulatory blood pressure measurement) of between 130 mmHg and 170 mmHg systolic and between 80 mmHg and 105 mmHg diastolic at baseline visit Exclusion Criteria
• Lacks appropriate renal artery anatomy for renal denervation
• Secondary hypertension other than sleep apnea
• Type 1 diabetes mellitus or uncontrolled Type 2 diabetes
• Any history of cerebrovascular event or severe cardiovascular event, within 6 months prior to consent
• Repeated hospitalization for hypertensive crisis (twice or more) within 12 months prior to obtaining consent, or any hospitalization for hypertensive crisis within 3 months prior to obtaining consent
• Patients prescribed to drugs that have antihypertensive effects for other chronic diseases, and the investigator considers that discontinuation of these drugs may pose a serious risk to health
• Patients who are taking drugs known to affect blood pressure and the investigator judges that it is not possible to discontinue these drugs during the study period
• Patients with a history of persistent or permanent atrial tachyarrhythmia
• Patients with active implantable medical devices
• Primary pulmonary hypertension
• Patients with contraindications or unacceptable anaphylactic reactions or uncontrolled allergy to contrast media
• Night shift workers
• Pregnant, nursing or planning to become pregnant
• Patients with any of the following central laboratory tests at screening
• Plasma aldosterone/renin ratio greater than or equal to 200 and plasma aldosterone greater than or equal to 60 pg/ml
• HbA1c greater than or equal to 8.0%
• eGFR less than 40 mL/min/1.73m2

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension
• Vascular Diseases

Intervention

Device:
• Paradise™ (PRDS-001) Renal Denervation Ultrasound System
Following renal angiogram according to standard procedures, subjects remain blinded and are randomized to treatment with renal denervation or sham control
• Renal Angiogram
Following renal angiogram according to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure

Locations

Country	Name	City	State
Japan	Fukuoka University Chikushi Hospital	Chikushino-shi	Fukuoka
Japan	Mitsui Memorial Hospital	Chiyoda-ku	Tokyo
Japan	St. Luke's International Hospital	Cyuo-ku	Tokyo
Japan	Fukuoka Sanno Hospital	Fukuoka-shi	Fukuoka
Japan	Kyushu University Hospital	Fukuoka-shi	Fukuoka
Japan	Minamino Junkanki Hospital	Hachioji-shi	Tokyo
Japan	Hamamatsu University Hospital	Hamamatsu-shi	Shizuoka
Japan	Hirosaki University Hospital	Hirosaki-shi	Aomori
Japan	Hiroshima City North Medical Center Asa Citizens Hospital	Hiroshima-shi	Hiroshima
Japan	Iwaki City Medical Center	Iwaki-shi	Fukushima
Japan	Kagoshima University Hospital	Kagoshima-shi	Kagoshima
Japan	Kanazawa University Hospital	Kanazawa-shi	Ishikawa
Japan	Kobe University Hospital	Kobe-shi	Hyogo
Japan	Chikamori Hospital	Kochi-shi	Kochi
Japan	Japanese Red Cross Kumamoto Hospital	Kumamoto-shi	Kumamoto
Japan	Kumamoto University Hospital	Kumamoto-shi	Kumamoto
Japan	Kurume University Hospital	Kurume-shi	Fukuoka
Japan	University Hospital Kyoto Prefectural University of Medicine	Kyoto-shi	Kyoto
Japan	Kimura Clinic	Meguro-Ku	Tokyo
Japan	Toho University Medical Center Ohashi Hospital	Meguro-ku	Tokyo
Japan	Tokyo Saiseikai Central Hospital	Minato-ku	Tokyo
Japan	Tokyo Takanawa Hospital	Minato-ku	Tokyo
Japan	Toranomon Hospital	Minato-ku	Tokyo
Japan	Miyazaki Medical Association Hospital	Miyazaki-shi	Miyazaki
Japan	Japanese Red Cross Musashino Hospital	Musashino-shi	Tokyo
Japan	Ryukyu University Hospital	Naha-shi	Okinawa
Japan	Nayoro City General Hospital	Nayoro-shi	Hokkaido
Japan	Niigata City General Hospital	Niigata-shi	Niigata
Japan	Nishinomiya Municipal Central Hospital	Nishinomiya-Shi	Hyogo
Japan	Okayama Rosai Hospital	Okayama-shi	Okayama
Japan	Osaka Saiseikai Nakatsu Hospital	Osaka-shi	Osaka
Japan	Tokyo Rosai Hospital	Ota-ku	Tokyo
Japan	Osaka Rosai Hospital	Sakai-shi	Osaka
Japan	Nihonkai General Hospital	Sakata-shi	Yamagata
Japan	Sapporo-Kosei General Hospital	Sapporo-shi	Hokkaido
Japan	Tonan Hospital	Sapporo-shi	Hokkaido
Japan	Chuno Kousei Hospital	Seki-shi	Gifu
Japan	Tohoku University Hospital	Sendai-shi	Miyagi
Japan	Nissan Tamagawa Hospital	Setagaya-ku	Tokyo
Japan	Jichi Medical University Hospital	Shimotsuke-shi	Tochigi
Japan	National Cerebral and Cardiovascular Center	Suita-shi	Osaka
Japan	Osaka University Hospital	Suita-shi	Osaka
Japan	Suzuka Chuo General Hospital	Suzuka-Shi	Mie
Japan	Tomakomai City Hospital	Tomakomai-shi	Hokkaido
Japan	Ehime University Hospital	Toon-shi	Ehime
Japan	Imamura Hospital	Tosu-shi	Saga
Japan	Tokyo Bay Urayasu Ichikawa Medical Center	Urayasu-shi	Chiba
Japan	Saiseikai Yokohamashi Nanbu Hospital	Yokohama-shi	Kanagawa
Japan	Yokohama City University Hospital	Yokohama-shi	Kanagawa
Japan	Yokohama Rosai Hospital	Yokohama-shi	Kanagawa
Japan	Sanin Rosai Hospital	Yonago-shi	Tottori

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Medical Devices Co., Ltd. Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in 24-hour systolic ABPM		From baseline to 3 months post-procedure
Secondary	Mean change in 24-hour systolic ABPM		from baseline to 6 months post-procedure
Secondary	Mean change in daytime/nighttime /24-hour ABPM (systolic/diastolic) (excluding primary and important secondary endpoints)		From baseline to 3, 6, 12 months post-procedure
Secondary	Change in mean sitting office blood pressure (systolic/diastolic)		From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 months post-procedure
Secondary	Change in mean home blood pressure (systolic/diastolic)		From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 months post-procedure
Secondary	Percentage of subjects with a mean decrease in daytime/nighttime/24-hour systolic ABPM of =5 mmHg, =10 mmHg, and =15 mmHg		3, 6, and 12months post-procedure
Secondary	Percentage of subjects who required a change in antihypertensive medication		at any time up to 12 months after the procedure
Secondary	Percentage of subjects who achieved blood pressure control without any change in antihypertensive medication		3, 6, 12 months after the procedure
Secondary	Percentage of subjects whose blood pressure was controlled by changing antihypertensive medication		3, 6, 12 months after the procedure
Secondary	Change in mean pulse pressure (difference between systolic and diastolic blood pressure) in the office, home, ABPM		3, 6, 12 months after the procedure
Secondary	Change in mean heart rate in the office, home, ABPM		3, 6, 12 months after the procedure